N/A
N=176
Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
Pain · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01181492 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: CYP3A4*1G Polymorphism — 103; 66; 7 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Huazhong University of Science and Technology
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CYP3A4*1G Polymorphism |
103; 66; 7 | — |
| SECONDARY The Visual Analog Scale 24 Hours Postoperative |
3.7; 3.7; 3.4 | — |
| SECONDARY PCA Fentanyl Consumption |
395.0; 359.8; 247.1 | — |
Summary
Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176 patients receiving elective lower abdominal surgery under general anesthesia were recruited into this study. Genotyping of CYP3A4*1G was carried out by direct sequencing. The plasma fentanyl concentration was detected 30 min after anesthesia induction by high performance liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24 h after operation. PCA fentanyl consumption and adverse effects were recorded during the first 24 h after surgery.
Eligibility Criteria
Inclusion Criteria
- Aged 20-65 years
- Anesthesiologists (ASA) physical status I or II;
- With ±20% of ideal body weight;
- Received PCA administration;
- Agreed to participate the research
Exclusion Criteria
- History of chronic pain;
- Psychiatric diseases;
- Diabetes mellitus;
- Severe cardiovascular diseases;
- Kidney or liver diseases;
- Alcohol or drug abuse (according to the criteria of DSM-IV);
- Pregnancy or at lactation period;
- Consumed drugs (1week) or foods (3 days) known to inhibit or induce the expression of CYP3A4 enzymes prior to surgery;
- Refused PCA administration;
- Disagree to participate to the research
Data sourced from ClinicalTrials.gov (NCT01181492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.